| RP-HPLC法测定头孢克肟的有关物质 |
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| 引用本文： | 张慧文,关倩明,林玲,肖彦琨. RP-HPLC法测定头孢克肟的有关物质[J]. 中国抗生素杂志, 2010, 35(3) |
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| 作者姓名： | 张慧文 关倩明 林玲 肖彦琨 |
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| 作者单位： | 广州市药品检验所,广州,510160 |
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| 摘 要： | 目的 建立测定头孢克肟有关物质的RP-HPLC方法.方法 采用Hypersil BDS C_(18)(4.6mm×250mm,10μm)色谱柱,流动相为0.1mol/L醋酸铵缓冲液(用氨试液调pH为7.0)-乙腈(96:4),流速1.0mL/min,检测波长254nm,柱温35℃.结果 头孢克肟在0.10-49.33μg/mL浓度范围内,峰面积与浓度呈良好线性关系(r=1.0000);最低检测限为0.18ng;各有关物质与主成份均达到基线分离.结论 本法简便、专属,可用于头孢克肟有关物质的测定.
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| 关 键 词： | 头孢克肟 有关物质 |
Determination of related substances in cefi xime by RP-HPLC |
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| Zhang Hui-wen,Guan Qian-ming,Lin Ling,Xiao Yan-kun. Determination of related substances in cefi xime by RP-HPLC[J]. Chinese Journal of Antibiotics, 2010, 35(3) |
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| Authors: | Zhang Hui-wen Guan Qian-ming Lin Ling Xiao Yan-kun |
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| Affiliation: | Zhang Hui-wen,Guan Qian-ming,Lin Ling , Xiao Yan-kun(Guangzhou Institute for Drug Control,Guangzhou 510160) |
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| Abstract: | Objective To establish a method for the determination of related substances in cefixime by RPHPLC. Methods The chromatographic separation of the related substances was performed on a Hypersil BDS C_(18) column(4.6mm×250mm, 10μm)with a mixture of 0.1 mol/L ammonium acetate (adjusted with ammonia solution to pH of 7.0) and acetonitrile (96 : 4) as mobile phase. The flow rate was 1.0mL/min. The detection wavelength was 254nm. The column temperature was 35℃. Results The calibration curve was linear within the range of 0.10-49.33μg/mL for cefixime (r= 1.0000). The detection limit of cefixime was 0.18ng. The cefixime could be separated effectively from its degradation product with the method. Conclusion This method is simple and selective for the determination of related substances in Cefixime. |
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| Keywords: | RP-HPLC Cefixime Related substances RP-HPLC |
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